evaluation of geistlich fibro-gide® + caf in comparison to ctg + caf for the treatment of recession defects at 6 months

Conditions: Gingival Recession

Summary: this double blind, randomized, split mouth study evaluates the non-inferiority of geistlich fibro-gide® in comparison to connective tissue graft for the treatment of miller class i or ii recession defects at 6 months post treatment.

this double blind, randomized, split mouth study evaluates the non-inferiority of geistlich fibro-gide® in comparison to connective tissue graft for the treatment of miller class i or ii recession defects at 6 months post treatment. a total sample size of 30 subjects (n=30) will be evaluated at 3 centers with 4 investigators. power analysis based on 80% power and past mcguire/ scheyer matched-pair defect recession coverage studies, with one-sided confidence interval 0.025, indicates that in order to detect a 12% difference in root coverage with ± 15% standard deviation a patient sample of 25 should be used . given the multi-center nature of this study and the intention to follow patients long-term, with normal attrition, 30 subjects will ensure adequate long-term follow-up and provide a "power buffer" for any outcome differences that might be seen between centers. 30 patients with miller class i or ii recession defects on bilateral sites will be treated randomly with coronally advanced flap (caf) in combination with either geistlich fibro-gide (gfg =test) on one side, and connective tissue graft (ctg = control) on the contralateral side of the mouth. follow-up visits after visit 2 surgery will be conducted at week 1,2, 4,12 and 24 and in the long term after 1,3 and 5 years.

Eligibility criteria:
inclusion criteria: * 18 to 75 years of age, inclusive. * subjects must have at least two teeth with buccal miller class i or ii recession type defects, 3 mm deep and 3 mm wide on the same tooth in the contralateral quadrant of the same jaw * defects should be similar in size and morphology * teeth with root canals should be asymptomatic, completed at least 6 months prior * at least 1mm kt * subjects with parafunctional habits must wear a bite guard to be included. exclusion criteria: * participation within the previous 30 days in other investigational clinical trials. * class v restorations or abfractions that obliterate the cej. * subjects whose teeth have extremely prominent root surfaces -greater than 2mm facially to the adjacent teeth measured at the level of the cej. * systemic conditions that could influence wound healing or any other conditions that would preclude periodontal surgery. * taking medications that compromise wound healing. * acute infectious lesions in the areas intended for surgery. * untreated moderate to severe periodontal disease. * weekly or more frequent use of nicotine products within the past 6 months. * females who are pregnant or lactating, or sexually active female subjects who are of childbearing potential and who are not using hormonal or barrier methods of birth control. * subjects who require sedation in order to undergo surgery. * molars, teeth with axial mobility or interproximal loss of attachment, or full coverage crowns or veneers do not qualify.

Keywords: gingival recession fibro-gide caf ctg geistlich